Determination of Lysine Requirements in Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Lysine intake

• Registration Number: NCT01776931
• Lead Sponsor: University of British Columbia

Brief Summary

Amino acids are building blocks of protein in our body. It is important that pregnant women eat adequate amount of protein/amino acids to ensure healthy growth and development of the fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and not much in plant foods such as wheat. Currently , it is not known how much lysine is needed to eat during pregnancy.

Current Dietary Reference Intake recommendations for amino acid requirements are based on non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators knowledge, there is no scientific information regarding the amount of lysine needed at different stages of pregnancy.

The investigators hypothesize that current recommendations for lysine intake in pregnant women are underestimated. The investigators also hypothesize that the lysine requirements will be greater during the later stages of pregnancy, compared to early stages.

The purpose of this study is to determine lysine requirements in healthy pregnant women 19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Singleton pregnancy
• Maternal age 19-40y
• Early stage of pregnancy(15-18 weeks) and late stage of pregnancy(33-36 weeks)
• In good health (free of chronic/acute illness, full range of physical mobility)
• Healthy pre-pregnancy body mass index

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Exclusion Criteria

• Subjects outside the age range of 19-40y
• Women pregnant with more than one child
• Body mass Index less than 18.5kg/m2 or greater than 25 kg/m2
• less than 18 months between current pregnancy and last pregnancy
• History of spontaneous abortion,pre-term birth, preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy related jaundice
• Existing metabolic disease
• Substance dependance (i.e. alcohol, cigarette, illicit drugs)
• Allergic to eggs and egg protein
• Severe nausea and vomiting during pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lysine intake	Lysine intake	Dietary supplement:lysine intake

Primary Outcome Measures

Name	Time	Method
13 carbon dioxide production	8 hours (1 study day)	Urine and breath samples will be collected during the study to measure the rate of oxidation of tracer in expired breath and flux by enrichment in urine.

Trial Locations

Locations (1)

Child & Family Research Institute; 🇨🇦 Vancouver, British Columbia, Canada